Trial of CPX-351 in Newly Diagnosed Elderly AML Patients

Completed · Phase 2

Conditions studied: Acute Myeloid Leukemia

In brief

The study investigates if CPX-351 will be a) more effective than the standard AML treatment and b) more tolerable than the standard AML treatment regimens. The study compares the investigational product CPX-351 vs the standard treatment for AML in this patients age group.

Key facts

Study ID

NCT00788892

Run by

Jazz Pharmaceuticals

People needed

126

Starts

2008-10-01

Expected to finish

2011-12-01

Last updated by the study team

2018-01-12

Who can join

Age: 60 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥60 and <76 years at the time of diagnosis of AML
• Pathological confirmation of AML
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Able to adhere to the study visit schedule and other protocol requirements
• Laboratory values fulfilling the following:
• Serum creatinine < 2.0 mg/dL Serum total bilirubin < 2.0 mg/dL Serum alanine aminotransferase or aspartate aminotransferase < 150 IU/liter Note: If elevated liver enzymes are related to disease; contact medical monitor to discuss.
• Cardiac ejection fraction > 50% by echocardiography or MUGA scan

You may not qualify if…

• Patients with locally advanced or metastatic solid tumors ≤5 years from initial diagnosis are excluded. (Patients with locally advanced or metastatic solid tumors >5 years from initial diagnosis, for whom the investigator has no clinical suspicion of active disease for >2 years before randomization are eligible)
• Prior treatment for AML; only hydroxyurea is permitted (see below)
• Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization
• Patients with a prior anthracycline exposure of greater than 368 mg/m2 daunorubicin (or equivalent)
• Any serious medical condition, laboratory abnormality or psychiatric illness that would prevent obtaining informed consent
• Administration of any antineoplastic therapy within 4 weeks of the first CPX-351 dose; in the event of rapidly proliferative disease use of hydroxyurea is permitted until 24 hours before the start of study treatment
• Clinical evidence of active CNS leukemia
• Patients with history of and/or current evidence of myocardial impairment (e.g. cardiomyopathy, ischemic heart disease, significant valvular dysfunction, hypertensive heart disease, and congestive heart failure) resulting in heart failure by New York Heart Association Class III or IV staging
• Active and uncontrolled infection. Patients with an infection receiving treatment with antibiotics may be entered into the study if they are afebrile and hemodynamically stable for 72 hrs.
• Current evidence of invasive fungal infection (blood or tissue culture); HIV or active hepatitis C infection
• Hypersensitivity to cytarabine, daunorubicin or liposomal products
• History of Wilson's disease or other copper-related disorder

Where it is running

• Arizona Cancer Center — Tucson, Arizona, United States
• Cedars Sinai Medical Center — Los Angeles, California, United States
• UC Davis Cancer Center — Sacramento, California, United States
• University of California Medical Center — San Francisco, California, United States
• University of Colorado Cancer Center — Aurora, Colorado, United States
• Shands Jacksonville Medical Center — Jacksonville, Florida, United States
• H Lee Moffitt Cancer Center and Research Institute — Tampa, Florida, United States
• Blood and Marrow Transplant Group of Georgia — Atlanta, Georgia, United States
• Robert H.Lurie Comprehensive Cancer Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• St.Francis Hospital — Beech Grove, Indiana, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Northern New Jersey Cancer Associates — Hackensack, New Jersey, United States
• North Shore University Hospital — Manhasset, New York, United States
• Weil Cornell Medical Center — New York, New York, United States
• New York Medical College, Division of Oncology — Valhalla, New York, United States
• Blumenthal Cancer Center/Mecklenburg Medical Group — Charlotte, North Carolina, United States
• Jewish Hospital — Cincinnati, Ohio, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pittsburg Cancer Center — Pittsburgh, Pennsylvania, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Joe Arrington Cancer Center — Lubbock, Texas, United States
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States
• Cancer Therapy and Research Center at the University of Texas — San Antonio, Texas, United States
• Froedlert Hospital/Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.